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Amid staff cuts, FDA looks to AI to 'optimise' reviews
The FDA has rolled out its highly-touted generative AI tool, almost a month early, with a promise to reduce the time taken for regulatory reviews.
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Axe falls on Stealth Bio staff after FDA rejects lead drug
Stealth BioTherapeutics' filing for Barth syndrome therapy elamipretide has been turned down by the FDA, but there may be a way forward for the drug.
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MSD and Daiichi Sankyo pull HER3-DXd's FDA filing
MSD and Daiichi Sankyo suffer another setback with their HER3 programme ahead of a crucial data readout at ASCO.
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Eisai says patent win blocks Lenvima generic to 2036
Eisai has won a lawsuit blocking FDA approval of Shilpa's generic of cancer blockbuster Lenvima until 2036, although the verdict could go to appeal.
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Manufacturing issues scupper Savara's lead drug filing
Savara shares are pummelled after the FDA says it cannot accept a filing for lead drug Molbreevi, but it is still hopeful of an approval in 2026.
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